Global Clinical Trials: How to Navigate Key Federal Compliance Requirements

What You Need to Know

Conducting research in different countries around the world can be a great way to increase equity and reliability of results. Researchers can draw from a more diverse patient pool, helping to ensure that new treatments are effective and safe for a wide range of patients.

However, while there are significant benefits to gain from conducting clinical trials with a global reach, there are additional responsibilities for research teams to consider. Researchers must carefully navigate an often complex web of regulations, especially when the trials are headed for FDA review at a later date. Understanding the requirements upfront can help ensure valid data and expedite regulatory approval later.

Guidelines to Follow

Conducting a successful clinical trial on a global scale means abiding by multiple regulatory frameworks at the same time. These guidelines often overlap and sometimes even clash, so a deep understanding of them is a prerequisite for ensuring data acceptance once the trial has reached its conclusion.

Just a few of the many regulations to abide by include:

Why Navigating Federal Guidelines is Critical

Abiding by these federal compliance guidelines isn’t just an exercise in box-checking; it represents a foundational commitment to valid and ethical clinical research. Why?

Common Pitfalls to Watch Out For

Well-meaning research teams can easily fall victim to unexpected compliance issues, especially when expanding to global trials. Anticipating these potential pitfalls and proactively addressing them is an important step. 

• Navigating regulatory differences between countries: International efforts to create universal frameworks are helpful, but there are often still significant differences in documentation requirements and approval guidelines. This is often made more difficult by a lack of cultural understanding and language barriers. 

• Limited infrastructure or resources in some regions: What might seem simple in a bustling clinical research market may be far more challenging in regions with much more limited resources. Teams must be ready to adapt while maintaining research and data quality standards. 

• Ensuring ethical oversight and independent reviews: International coordination between ethics committees and local authorities is only possible after careful planning and requires frequent communication. 

• Not engaging experts early enough: A lack of experience in global clinical trials sets research teams up for trouble down the road. Obtaining experienced guidance from a Contract Research Organization (CRO) early on can help identify gaps before they become problematic. 

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Frequently Asked Questions

1. How do researchers know which regulations apply to them? 

Broadly speaking, researchers are obligated to abide by the rules and regulations of every region where they are conducting research. For FDA-eligible projects or those with federal funding, U.S. regulations apply universally, no matter where the trial is conducted. Regardless of location, Good Clinical Practice (GCP) standards will apply, too.

2. What is the best way to ensure research compliance? 

Enlisting the help of regulatory experts in the earliest stages of trial design is vital to identifying challenges before they threaten the integrity of the research. Ongoing monitoring and continuous staff training will help teams stay on top of rapidly changing regulations, while frequent communication with ethics committees and local authorities ensures the trial proceeds without costly delays. 

For example, a sponsor who involves compliance specialists from the trial design phase may be more likely to identify and address documentation gaps before data submission, preventing costly delays.

3. What are red flags that could trigger FDA rejection of research data? 

Many things can derail an FDA approval, including a lack of informed consent documentation, failure to gain approval from ethics boards, and failure to follow crucial guidelines. For example, the FDA has rejected data from overseas trials where researchers failed to document informed consent in the local language.

How Rubix LS Can Help Navigate Global Clinical Trials

At Rubix LS, we specialize in helping life sciences organizations streamline the often confusing process of performing global clinical trials. Our team works closely with researchers to ensure compliance with FDA, ICH GCP, and other global regulatory frameworks.

With Rubix LS, you’ll get:

Whether you are expanding a study site internationally or preparing foreign data for FDA submission, Rubix LS ensures you stay compliant, efficient, and trusted.

Contact us today, or check out our services here: Rubix LS Capabilities Deck